Friday, August 17, 2012

Association for Molecular Pathology v. US PTO Decided on Remand

As reported
in previous posts, on petition for certiorari the Supreme Court vacated the
Federal Circuit's 2011 decision in Association for Molecular Pathology v. US
PTO and remanded the case for further consideration in light of its decision in
Mayo v. Prometheus. Yesterday, the Federal Circuit issued its decision on
remand. Of course, this might not be the end of the story, since the plaintiffs
will presumably petition for rehearing by the en banc Federal Circuit and/or certiorari
by the Supreme Court. Some believe that the Supreme Court is likely to grant
certiorari, based on the diverging opinions of the three Federal Circuit
judges, and the arguably short shrift given by the majority to the relevance of
Mayo to the Myriad claims.

Not
surprisingly, the Mayo decision and the parties' subsequent re-briefing and re-arguing of
the case did not alter the views of any of the three Federal Circuit judges
deciding the case. As was the case in the first decision, the judges all agreed that the claims directed towards
methods of testing for genetic variations in the BRCA genes are patent
ineligible. The majority (Judges Lourie and Moore) held the claims to isolated DNA molecules and the claim reciting a
method for using a cell-based assay to screen for potential cancer drugs (claim
20) to be patent eligible. Judge Bryson, in dissent, agreed that claim 20 is
patent eligible, but maintained his earlier position that the isolated DNA
claims are patent ineligible, based largely on perceived policy concerns.

Writing for
the majority, Judge Lourie noted that the only issue to be considered on remand
was the applicability of the Supreme Court’s Mayo holding to the patent
eligibility of the claims at issue.He
emphasized that the court was not addressing the overall patentability of the
claims, only the eligibility of the claimed subject matter for patent
protection, nor was the court addressing the policy concerns that had been raised with respect to "gene patents" and Myriads patent enforcement and licensing practices.

With respect to the isolated DNA claims, Judge Lourie
found that Mayo "does not control," because the claims are directed
towards compositions of matter, not methods. Recall that all of the claims at
issue in Mayo were directed towards processes, not compositions of matter, and
many (including myself) have arguedthat Mayo is not applicable to composition
of matter claims.

Judge Lourie
appears to have adopted this position, explaining that “while Mayo and
earlier decisions concerning method claim patentability provide valuable
insights and illuminate broad, foundational principles, the "the Supreme
Court’s decisions in Chakrabarty and Funk Brothers set out the
primary framework for deciding the patent eligibility of compositions of matter,
including isolated DNA molecules.” Based on this premise, he ruled that “the
issue of patent-eligibility [with respect to composition of matter claims] remains,
as it was on the first appeal to this court, whether they claim patent ineligible
products of nature.” In the view of the majority, the claimed isolated DNA molecules are not found in nature,
and hence are not products of nature, but rather patent eligible compositions
of matter.

The majority
also held that Mayo did not alter the outcome with respect to the method
claims. The patent ineligibility of the method of diagnostic claims was a
foregone conclusion - as interpreted by
the Federal Circuit, they could be infringed by merely comparing DNA sequence
information, and hence lie much further down the spectrum of patent
ineligibility than the claims at issue in Mayo, which at least involved a
physical step of analyzing a blood sample taken from a patient.

The patent
eligibility of claim 20 was more in doubt. Conceivably, the claim could have
been found patent ineligible under a broad reading of Mayo. In fact, Eli Lilly
submitted an amicus brief arguing that claim 20 was patent ineligible because
it involved a step that could be performed in the mind. If the court had
adopted Lilly’s radical theory of patent eligibility, it could have drastically
constricted the range of patent eligible methods (and in doing so substantially
eased the freedom to operate concerns of research pharmaceutical companies such
as Eli Lilly). However, the court declined to go down this route, and did not
even mention Lilly’s proposal.

Judge Lourie
essentially held claim 20 to be patent eligible because the claimed method is
based on a man-made, non-naturally occurring (and hence patent eligible) material,
i.e., a cell transformed with a BRCA gene.This is an interesting interpreation of Mayo. Recall that the method claims found to
be patent ineligible in Mayo all
center around the analysis of man-made, non-naturally occurring (and hence
presumably patent eligible) drugs and drug breakdown products.Judge Lourie chose not explain the
distinction between claim 20 and the method claims at issue in Mayo.

Questions
Remaining

The decision
leaves unanswered a number of questions. For example, the majority's decision
with respect to the isolated DNA claims seems to depend upon the chemical structural
differences between the claimed isolated DNA and DNA that occurs naturally. In
particular, Judge Lourie emphasized that the isolation of DNA molecules
inherently involves the breaking of covalent bonds, and hence the isolated DNA
molecule is chemically distinct from its natural counterpart. Where does that
leave isolated natural products that are not chemically distinct from their
natural counterpart, i.e., what if the isolation of a natural product does not
inherently involve breaking covalent bonds?

Judge Lourie
makes much of a perceived distinction between "isolation" and
"purification" of DNA molecules, and seems to suggest that the mere
purification of a natural product might not be sufficient for patent eligibility.
This is concerning, because isolated natural products have long been considered
patent eligible.The amicus brief
submitted by the Biotechnology Industry Organization provides numerous examples
of non-DNA isolated natural products that have been patented, and that have
proven highly beneficial to society.

There is
also the important question of to what extent methods of diagnostic testing,
and personalized medicine, or eligible for patent protection in view of
Mayo.The Myriad method of diagnostic
claims held to be patent ineligible in this case were interpreted by the court
to cover the mere mental comparison of genetic sequence information, and
clearly such claims are patent ineligible. But the vast majority of diagnostic claims
involve physical steps such as obtaining physical samples from patients,
performing clinical tests on the sample, and/or using the information generated
in the treatment of a patient. It is not clear at this point how these claims
would fare under a Mayo analysis, but Judge Lourie's opinion with respect to
claim 20 suggests he would interpret Mayo in a manner that would maintain
patent eligibility of at least some diagnostic/personalized medicine claims, if
drafted more narrowly than Myriad’s claims.

8 comments:

Anonymous
said...

Good point on the isolation/purification of natural products. Can you direct us to relevant court cases concerning such that rely more on utility and intervention by man than on structural differences?

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About Me

I am a law professor at the University of Missouri-Kansas City School of Law. My primary research interests lie at the intersection of biotechnology and intellectual property. This blog provides analysis and commentary on recent developments relevant to this area of the law.